Status:
COMPLETED
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Lead Sponsor:
Pfizer
Conditions:
Moderate to Severe Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitre...
Eligibility Criteria
Inclusion
- Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
- In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
- Negative urine pregnancy test before the first dose of study drug in all female patients
Exclusion
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00936065
Start Date
July 1 2009
End Date
April 1 2011
Last Update
April 9 2012
Active Locations (10)
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1
Pfizer Investigational Site
Daejeon, Korea, South Korea, 301 721
2
Pfizer Investigational Site
Gyeonggido, Korea, South Korea, 420 717
3
Pfizer Investigational Site
Seoul, Korea, South Korea, 110 744
4
Pfizer Investigational Site
Seoul, Korea, South Korea, 130 702